MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR

Model Number 70105.3815

Device Problems Partial Blockage (1065); Occlusion Within Device (1423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) requested the device for investigation.A supplemental medwatch will be submitted when additional information becomes available.Additional information: the product mentioned is a tubing set and the included affected component has the contributing design function of the quadrox-id which is registered under 510 (k): k101153.(b)(4).

Manufacturer Narrative

For further investigation the product was opened with a milling machine.The mats and grids have been visual inspected.Thereby no clotting was found.Clotting is a known phenomenon to maquet cardiopulmonary (b)(4).As there were no clots between the mats inside the oxygenator the failure was determined to not be attributed to a device related malfunction.Based on these results and the information available at this time, the oxygenator in question operated within maquet cardiopulmonary specifications.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).The device was evaluated visually and a tightness test was performed.During visual inspection clotting was noticed.A deformed blood outlet connector and a crack on blood inlet connector were detected.Leakage from the gas outlet port was detected during tightness testing.Due to this leakage, the device could not be tested for pressure drop performance.Device history record review was satisfactory.Additional testing will be performed.A supplemental medwatch will be submitted when information becomes available.

Event Description

(b)(4).

• Brand Name: QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; 2229321132
• MDR Report Key: 4763077
• MDR Text Key: 18070244
• Report Number: 8010762-2015-00432
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 07/01/2016
• Device Model Number: 70105.3815
• Device Catalogue Number: HMOD 70000-USA
• Device Lot Number: 70100775
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/20/2015
• Date Manufacturer Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: 8010762-02/18/2015-001C
• Patient Sequence Number: 1